Industry attempts to standardize the biological effects of natural herbal products range from the age old practice of ritualistic harvest at specific times of the day and/or year to the contemporary method of selecting chemical compounds as makers then measuring the potency of the product proportional to the quantity of the marker, the "more is better" concept. However, while chemical marker analysis is necessary for identity and purity determination, data produced through previous research indicates that, in the case of Hydrastis canadensis L. (goldenseal), simply measuring chemical marker level content within a whole plant matrix does not present an accurate means of predicting product bio-activity. This SBIR proposal seeks to develop a viable marketing plan for a unique method of standardizing goldenseal products to specified levels of bioactivity relative to a known reference standard. These products have been branded Hydrastis Completetm. In addition to offering a more reliable consumer product than currently exists, the method significantly increases grower profitability over a four year rotation through use of the whole plant and production of value-added products. While Hydrastis Completetm represents a new paradigm in goldenseal product reliability and renders other standardization methods obsolete, traditional herbal product consumers can be very traditional in the concepts which guide their purchases and therefore potentially reluctant to embrace a new product idea unless it is properly presented. Therefore the challenge faced by OrganiPharm and its member/growers is to develop a marketing plan which will utilize solid science, sound reasoning, and simple logic to cut through unfounded preconceptions and outdated traditions regarding Hydrastis. Successful completion of Phase I of this project will build on previous SBIR work and determine provide the data necessary to develop a viable plan for bringing Hydrastis Completetm to the mainstream dietary supplement market. This will provide greater consumer satisfaction with the products they purchase as well as reduce the incidence of undesirable side effects caused by adulterants/contaminants. Small farm viability will be enhanced through a more efficient use of the whole plant and the project will provide a desirable environmental benefit by focusing consumer attention on high quality cultivated goldenseal products ultimately resulting in a reduction in the need for wild collected Hydrastis (an internationally protected species) to meet market demand.
